Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medi-Tate Ltd.
ClinicalTrials.gov Identifier:
NCT01436877
First received: September 14, 2011
Last updated: July 17, 2014
Last verified: July 2014

September 14, 2011
July 17, 2014
September 2011
December 2014   (final data collection date for primary outcome measure)
Device related and unanticipated SAE [ Time Frame: At 3 months ] [ Designated as safety issue: Yes ]
Device related and unanticipated SAEs will be followed. No such SAEs are expected.
Same as current
Complete list of historical versions of study NCT01436877 on ClinicalTrials.gov Archive Site
  • Reduce at least 3 point in the International Prostate Symptom Score (IPSS) in at least 75% of subjects [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
    Questionnaire of IPSS will be done in each visit.
  • Increase of maximal urinary peak flow by at least 3 ml/s in at least 75% of subjects [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
    Maximal uroflow will be measured in each visit
Same as current
Not Provided
Not Provided
 
Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia
One-arm Feasibility and Prospective Pivotal Study to Assess the Safety and Efficacy of MediTate Temporary Implantable Nitinol Device (TIND) in Subjects Presenting Bladder Outlet Obstruction Secondary to BPH

The purpose of this study is to assess the safety and efficacy of MediTate Temporary Implantable Nitinol Device (TIND) used to alleviate symptoms of Bladder Outlet Obstruction (BOO) secondary to Benign Prostate Hyperplasia (BPH).The TIND is inserted in the bladder neck and prostatic urethra under local anesthesia for few days and taken out some 5 days later in the doctors office.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bladder Neck Obstruction
  • Benign Prostate Hyperplasia
Device: Insertion of Temporary Implantable Nitinol Device (TIND)
Subjects will be inserted with the Temporary Implantable Nitinol Device (TIND) to the bladder neck and urethral prostate for 5 days and thereafter the TIND will be withdrawn in the doctor office.
Experimental: device
Insertion of Temporary Implantable Nitinol Device (TIND)
Intervention: Device: Insertion of Temporary Implantable Nitinol Device (TIND)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
6
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

Main IC:

  • Subject signed informed consent prior to the performance of any study procedures.
  • Male with BPH, who are at least 50 years of age and that were diagnosed with BOO.
  • IPSS symptom severity score ≥ 10.
  • Peak urinary flow of < 12 ml/sec
  • No pathology found with kidney US
  • Prostatic urethra length < 30 mm
  • Prostate volume < 35 cc
  • Normal Urinalysis and urine culture.

Exclusion Criteria:

Main EC:

  • Any prior prostate treatment
  • Suspected or proved carcinoma of prostate
  • Urethral stricture
  • Urinary bladder stones
  • Serum prostate specific antigen level > 4 ng/ml (unless proved to be carcinoma free by biopsy).
  • Active urinary tract infection as determined by positive culture, bacterial prostatitis within the past year documented by positive culture.
  • Median prostatic lobe enlargement or a prominent obstructing "ball valve" prostatic lobe.
  • Subject has an interest in future fertility and is not willing to undergo fertility treatments whatsoever.
  • Any serious medical condition likely to impede successful completion of the study

Intraoperative EC:

  • Irregular findings by the implanting physician during the implantation procedure by the cystoscopy that to the best of the implanting physician are exerting non compliance with the exclusion or inclusion criteria and that were not noticed previously during screening
Male
50 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01436877
MT-01
No
Medi-Tate Ltd.
Medi-Tate Ltd.
Not Provided
Principal Investigator: Roy Farfara, MD Bnai Zion Medical Center, Haifa, Israel
Medi-Tate Ltd.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP